United States District Court, District of Columbia
CIGAR ASSOCIATION OF AMERICA, et al. Plaintiffs,
U.S. FOOD AND DRUG ADMINISTRATION, et al., Defendants.
P. MEHTA UNITED STATES DISTRICT JUDGE.
public health organizations (the “Proposed
Intervenors”) seek to intervene in this case to defend
regulations issued by the U.S. Food and Drug Administration
that subject cigars, pipe tobacco, and other tobacco products
to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §
301 et seq., as amended by the Family Smoking Prevention and
Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1777
(2009) (“Tobacco Control Act”). Plaintiffs,
associations that represent cigar manufacturers, retailers,
and importers, challenge the FDA's (1) adoption of
warning label requirements for cigar and pipe tobacco
products; (2) imposition of user fees on cigar and pipe
tobacco products but not e-cigarettes; (3) treatment of
retailers who blend pipe tobacco as “tobacco product
manufacturers”; and (4) classification of pipes as
“components” of tobacco products. Of those
challenges, Proposed Intervenors' motion to intervene is
predicated primarily on Plaintiffs' first challenge-the
new warning requirements for cigar and pipe tobacco products.
Proposed Intervenors contend that, if Plaintiffs are
successful, then they will be forced to spend resources
educating the public about the risks of tobacco use that
otherwise would be conveyed by the warnings themselves. That
additional expenditure of resources, they believe,
establishes the injury-in-fact necessary to demonstrate
Article III standing and constitutes the legal interest
required to intervene as of right under Rule 24(a) of the
Federal Rules of Civil Procedure.
careful consideration of the briefs and the record, the court
concludes that Proposed Intervenors have not established that
they would suffer a legally sufficient injury-in-fact if
Plaintiffs were to prevail in this litigation. Therefore,
they lack standing to intervene as of right, and the court
declines to allow Proposed Intervenors to intervene
permissively. Accordingly, the court denies Proposed
Intervenors' Motion to Intervene.
Plaintiffs' Challenge to the Rule
2009, Congress passed the Family Smoking Prevention and
Tobacco Control Act (“Tobacco Control Act”),
which granted the U.S. Food and Drug Administration the
authority to regulate cigarettes and other tobacco products.
See 21 U.S.C. § 387a. Congress immediately
applied the Act to “all cigarettes, cigarette tobacco,
roll-your-own tobacco, and smokeless tobacco”
(“Originally Regulated Products”). Id.
§ 387a(b). Congress left it to the FDA to decide whether
to apply the Act to other types of tobacco products.
Specifically, it vested in the FDA the authority to
“deem[ ]” “any other tobacco product[
]” subject to the Act. Id.
2016, the FDA exercised its “deeming” muscle. It
published a Final Rule (“Rule”) designating
cigars, pipe tobacco, and certain other tobacco products
(e.g., e-cigarettes) as “other tobacco products”
subject to the Tobacco Control Act. See Deeming Tobacco
Products To Be Subject to the Federal Food, Drug, and
Cosmetic Act, as Amended by the Family Smoking Prevention and
Tobacco Control Act; Restrictions on the Sale and
Distribution of Tobacco Products and Required Warning
Statements for Tobacco Products, 81 Fed. Reg. 28, 973
(May 10, 2016) (to be codified at 21 C.F.R. pts. 1100, 1140,
1143). The FDA's action made cigars and pipe
tobacco subject to requirements currently in place for
Originally Regulated Products, such as pre-market review, a
prohibition on the sale of products with descriptors such as
“light” and “mild, ” and ingredient
reporting. Id. And, critically, for present
purposes, the Rule included comprehensive warning
requirements for cigar and pipe tobacco packaging and
advertising. 81 Fed. Reg. at 28, 974. That provision mandates
that cigar manufacturers, distributors, importers, and
retailers include one of six health warnings on cigar and
pipe tobacco packages and in cigar and pipe tobacco
advertisements, as well as rotate those six warnings in a
manner that ensures consumers see all six. 81 Fed. Reg. at
29, 060-29, 062. The provision also sets font size, location,
and other requirements for displaying the warnings and
mandates the submission of warning plans. Id.
associations that represent cigar manufacturers, importers,
distributors, retail shops, suppliers, and consumers-filed
suit in July 2016 to challenge the Rule in multiple respects
as unlawful under the Tobacco Control Act, the Administrative
Procedure Act (the “APA”), and the First and
Fifth Amendments to the United States Constitution. Compl.,
ECF No. 1 [hereinafter Compl.], ¶¶ 4-5. Though
filed more than a year ago, this suit has barely gotten off
the ground. Following Defendants' answering of the Complaint
and Plaintiffs' filing of an initial motion for summary
judgment, the change in presidential administrations caused
the parties to seek multiple extensions of the briefing
schedule “to allow new leadership personnel at the
Department of Health and Human Services to more fully
consider the issues raised in this case and determine how
best to proceed.” Joint Mot. to Amend Scheduling Order,
ECF No. 27; Joint Mot. to Amend Scheduling Order, ECF No. 34.
The parties hoped that the extensions of time would enable
them to resolve the pending disputes or, at least, narrow the
additional time proved to be partially successful from
Plaintiffs' perspective. On July 28, 2017, the FDA
announced a “new comprehensive plan” for
regulating tobacco products that delayed implementation of
the Rule in several important respects. Pls.' Opp'n
to Mot. to Intervene, ECF No. 44 [hereinafter Pls.'
Opp'n], Ex. A, ECF No. 44-1 [hereinafter Pls.'
Opp'n, Ex. A]. The FDA extended to August 8, 2021, the
deadline for tobacco manufacturers to submit applications for
newly regulated products, including cigars and pipe tobacco,
that were on the market as of August 8, 2016, and provided
that manufacturers could continue to market those products
while the applications were pending. Pls.' Opp'n, Ex.
A at 2; Joint Status Report, ECF No. 51, ¶ 3. The FDA
also announced that it would seek public comment on (1) the
role that flavors in tobacco products play in attracting
youth and (2) the patterns of use and resulting public health
impacts of premium cigars, thereby suggesting that future
rulemaking may result in the Rule's amendment. Joint
Status Report, ECF No. 51, ¶ 3. The FDA otherwise left
the Rule intact, including its comprehensive warning
requirements for cigars and pipe tobacco.
response to the “new comprehensive plan, ”
Plaintiffs limited the number of claims presented. Plaintiffs
identified six claims as the ones they wished to pursue at
this time. Id. ¶ 5. On October 3, 2017,
Plaintiffs moved for summary judgment as to those claims and
sought order enjoining the warning requirements. Pls.'
Mot. for Prelim. Inj., ECF No. 61; Pls.' Mot. for Partial
Summ. J., ECF No. 62 [hereinafter Pls.' Mot. for Partial
Summ. J.], at 2-4. Defendants' opposition brief is due on
October 24, 2017. See Order, Sept. 19, 2017, ECF No.
The Proposed Intervention
Proposed Intervenors-the American Academy of Pediatrics, the
American Cancer Society Cancer Action Network, the American
Heart Association, the American Lung Association, the
Campaign for Tobacco-Free Kids, and the Truth Initiative-are
six public health organizations that seek to defend the Rule
against Plaintiffs' challenges. The court granted the
Proposed Intervenors' initial request to participate in
this matter as amici. Order, Apr. 3, 2017, ECF No. 30. On
July 24, 2017, however, the Proposed Intervenors sought to
upgrade their status to that of parties and filed a Motion to
Intervene as defendants (the “Motion”), citing
“recent indications that Defendants may not
aggressively defend the [Rule], or may seek to alter or
rescind the Rule.” Mot. to Intervene, ECF No. 36
[hereinafter Mot. to Intervene], at 3.
light of the parties' then-ongoing discussions about the
scope of their disputes, the court deferred ruling on
Proposed Intervenors' Motion until Plaintiffs identified
the claims that they presently wish to litigate. Order, Aug.
18, 2017, ECF No. 49. On September 5, 2017, Plaintiffs made
known the narrowed set of claims that are now before the
court. Joint Status Report, ECF No. 51. The parties and
Proposed Intervenors then supplemented their intervention
papers. See Suppl. Mem. in Supp., ECF No. 54;
Defs.' Supp. Resp. to Mot. to Intervene, ECF No. 58;
Proposed Intervenors' Suppl. Br. in Supp. [hereinafter
Suppl. Br. in Supp.], ECF No. 59; Pls.' Suppl. Br. in
Opp'n, ECF No. 60. Therefore, Proposed Intervenors'
Motion is now ripe for consideration.
Proposed Intervenors' Primary Interest in the Claims
Presently Before the Court
turning to the merits of the Motion, the court places
Proposed Intervenors' intervention request in the context
of the claims that are presently before it. This context
informs the court's analysis.
discussed, of their nine original claims, Plaintiffs
presently move for summary judgment as to six. The six claims
are as follows: (1) the Rule's imposition of user fees on
domestic manufacturers and importers of cigars to fund
FDA's regulation of tobacco products violates the APA
(Count II) and the Fifth Amendment (Count III); (2) the
Rule's warning requirements violate the First Amendment
(Count VII), the APA (Count VI), and the Tobacco Control Act;
(3) the Rule's treatment of retailers who blend pipe
tobacco as “manufacturers” violates the APA
(Count VIII); and (4) the Rule's classification of pipes
as “components” of a tobacco product subject to
regulation, rather than accessories not subject to
regulation, violates the APA (Count IX). Compl. at 28-37;
Pls.' Mot. for Partial Summ. J. at 2-4. In their original
moving papers, Proposed Intervenors stated that they intended
to take no position with respect to the user-fee issue. Mot.
to Intervene at 6 n.6. In addition, through their silence,
Proposed Intervenors implicitly have advanced no interest in
the claims concerning the classification of retailers who
blend pipe tobacco as “manufacturers” or the
treatment of pipes as “components” of a tobacco
product. Neither Proposed Intervenors' original motion
nor its supplemental briefing state any interest in, or
intention to defend the Rule as to, those two issues.
See, e.g. Id. at 13-14, 17 (asserting standing and a
legal interest based on the “availability of
unregulated cigars”); Suppl. Br. in Supp. at 2
(identifying only Plaintiffs' challenge to the warning
requirements as implicating Proposed Intervenors'
short, Proposed Intervenors' advance just one interest in
defending the Rule against Plaintiffs' present set of
claims-preserving the Rule's warning requirements. With
that interest in mind, the court now turns to the merits of
Proposed Intervenors' Motion.
Intervenors seek to intervene as defendants as of right under
Rule 24(a)(2) of the Federal Rules of Civil Procedure or,
alternatively, with the court's permission under Rule
24(b)(1). The court first considers intervention as of ...